MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-03 for 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM N/A 00-1300-0640 manufactured by Orthopediatrics, Corp.
[186558640]
Reference: (b)(4). Concomitant medical products: 5. 5/ 6. 0 uniaxial pedicle screw 6. 0mm x 40mm, item number: 00-1300-0640, lot number: unknown. Complaint sample was not returned for evaluation, scrapped by the hospital. Reported event was confirmed by review of customer submitted radiographs and ct films. Dhr review was unable to be performed as the lot number of the involved device is unknown. Risk management file review was deemed appropriate. Review of the complaint history determined that no further action is required as there were no trends identified. Root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[186558641]
It was reported the patient presented complaining of pain at the lower end of the implanted spinal construct. Radiographs and ct scan showed a lack of fusion at the lower level. Two pedicle screws were found to be broken and a revision surgery was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2020-00039 |
| MDR Report Key | 9779731 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-18 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LEIGH JESSOP |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 2670872 |
| Manufacturer G1 | ORTHOPEDIATRICS, INC |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM |
| Generic Name | RESPONSE 5.5/6.0 SYSTEM |
| Product Code | OSH |
| Date Received | 2020-03-03 |
| Model Number | N/A |
| Catalog Number | 00-1300-0640 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, CORP |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-03 |